NCT06281574

Brief Summary

Shoulder arthroplasty is becoming increasingly common, due to ageing of the population. Historically, surgeons have been reluctant to use a shoulder replacement in younger patients. During the last decades however, there was an improvement of surgical techniques and implants which resulted in the fact that these procedures are nowadays more frequently used in younger patients. Combined with the increasing life expectancy and the increased age of retirement, both elderly and younger patients hope to continue their jobs after prosthetic replacement. Recent literature shows that the majority patients is able to resume their work following shoulder arthroplasty. This study aims to analyze the RTW percentage in a Belgian cohort of patients with a shoulder replacement. This study hopes to identify factors that might influence the RTW.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2025

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

1.1 years

First QC Date

February 19, 2024

Last Update Submit

July 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Return to work

    Collection how many of the study participants will return to work after a shoulder arthroplasty. This question is answered with yes or no.

    Baseline

Secondary Outcomes (7)

  • Type of shoulder arthroplasty

    Baseline

  • WORQ-UP (work-related questionnaire for upper extremity disorders)

    Baseline

  • SSV (Subjective Shoulder Value)

    Baseline

  • SST (Dutch translation of the Simple Shoulder Test)

    Baseline

  • OSS (Oxford Shoulder Score)

    Baseline

  • +2 more secondary outcomes

Study Arms (1)

Patients with shoulder arthroplasty

Including all surgical interventions (anatomic total shoulder arthroplasty, humeral head hemi arthroplasty or reversed shoulder arthroplasty) for patients with shoulder arthroplasty

Procedure: Questionnaires

Interventions

To assess the shoulder function, the following questionnaires will be used: The validated Dutch translation of the Oxford Shoulder Score (OSS) The validated Dutch translation of the Simple Shoulder Test (SST) The Subjective Shoulder Value (SVV) To assess the work ability patients will use the validated Dutch work-related questionnaire for upper extremity disorders (WORQ-UP)

Patients with shoulder arthroplasty

Eligibility Criteria

Age18 Years - 63 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Population of patients with a shoulder arthroplasty surgery between January 2010 and January 2022 at University Hospitals Leuven.

You may qualify if:

  • Current evidence suggests that no significant changes in functionality can be expected 2 years after surgery. Therefore, we will include patients who were operated between January 2010 and January 2022 at the University Hospital Leuven
  • Patients ≥ 18 years old and ≤ 63 years old at time of surgery
  • Implantation of an anatomic total shoulder arthroplasty, humeral head hemi arthroplasty or reversed shoulder arthroplasty

You may not qualify if:

  • Age \< 18 and \> 63 years at time of surgery
  • Limited knowledge of Dutch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Filip Verhaegen

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2024

First Posted

February 28, 2024

Study Start

February 13, 2024

Primary Completion

March 27, 2025

Study Completion

March 27, 2025

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations